FDA Inspection
Glanbia Nutritionals NA, Inc.Glanbia Nutritionals NA, Inc. – FDA Inspection, Dec 22, 2010
Record Details
This FDA Inspection record concerns Glanbia Nutritionals NA, Inc., with an inspection on December 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 22, 2010
- Product Type
- Drugs
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ID · 4e89e6c3-6e19-485c-b388-314b31d7056f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702098
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.186(b)(6)Weight or measure at stages of processing
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.101(a)Batches Formulated to less than 100%
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Glanbia Nutritionals NA, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 6, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 22, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 19, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Glanbia Nutritionals NA, Inc.
- FDA Inspection 1228938 - 2024-03-25
- FDA Inspection 1231110 - 2024-02-06
- FDA Inspection 1154618 - 2021-09-22
- FDA Inspection 1147237 - 2021-07-19
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